Accolade 6721-0837Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540669537), received between Apr 2, 2018 and May 28, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Degraded” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2014 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2024 DUE TO INCREASING PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND ALTR.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 25315223 ↗
• InjuryOct 23, 2024Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED BY COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON MARCH 1, 2016, AND WAS IMPLANTED WITH AN LFIT COCR FEMORAL HEAD. HE WAS REVISED ON MARCH 27, 2024, DUE TO ALLEGED PERSISTENT PAIN, ELEVATED METAL ION LEVELS AND CORROSION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20514574 ↗
• InjuryOct 16, 2024Corroded; Corroded

  IT WAS REPORTED BY COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH AN LFIT COCR FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2023, DUE TO ALLEGED CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 20460316 ↗
• InjuryJan 5, 2024Corroded; Corroded

  IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT LEFT THA ON (B)(6) 2018, AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. HE WAS REVISED ON (B)(6) 2022, ALLEGEDLY DUE TO CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 18450631 ↗
• InjuryNov 7, 2023Degraded; Degraded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2014 AND THE FEMORAL HEAD WAS EXPLANTED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE PER OP REPORT: "THERE WAS BLACK MATERIAL AROUND THE MARGINS OF THE COBALT CHROME HEAD WHERE IT ATTACHED TO THE TRUNNION OF THE FEMORAL STEM. THIS EXTENDED CIRCUMFERENTIALLY AND THIS MATERIAL WAS CAREFULLY REMOVED AND PRESERVED. THE FEMORAL HEAD WAS REMOVED AND AREAS OF BLACK DEBRIS WERE NOTED INSIDE THE COBALT CHROME FEMORAL HEAD AND AROUND THE MORSE TAPER OF THE FEMORAL STEM."

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 18081992 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY THA SURGERY WAS DONE ON (B)(6) 2021. AN X-RAY IN THE FIRST POSTOPERATIVE WEEK REVEALED A FEMUR FRACTURE. OBSERVATION ONLY. NO SPECIFIC TREATMENT WAS PERFORMED. PATIENT WAS RECOVERY AT (B)(6) 2021.

  Patient problems: Bone Fracture(s)

  MAUDE report 17359495 ↗
• InjuryJul 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: PATIENT¿S LEFT HIP (STEM, HEAD AND MDM POLY) WERE REVISED DUE TO PERI PROSTHETIC FRACTURE AFTER A FALL.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17284207 ↗
• InjuryMar 8, 2023Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER LEFT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2022. IT IS FURTHER ALLEGED THAT THE PATIENT HAD ELEVATED SERUM CHROMIUM AND COBALT LEVELS AND DUE TO WEAR OF THE TRUNNION SUFFERED A FRACTURE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16504005 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: PATIENT'S LEFT HIP REVISED DUE TO A FALL AND PERIPROSTHETIC FRACTURE. AN ACCOLADE II STEM, BIOLOX HEAD, AND ADM/ MDM POLY INSERT WERE REVISED TO A RESTORATION MODULAR STEM, ANOTHER BIOLOX HEAD, AND ANOTHER ADM/ MDM POLY INSERT. SPOKE TO REP. REP CONFIRMED: FEMORAL FRACTURE, NO ALLEGATIONS AGAINST THE REVISED HEAD OR POLY, AND NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 15977635 ↗
• InjuryApr 9, 2021Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated

  HEAD DISASSOCIATED FROM THE STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11645426 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE (POSSIBLE CAUSE OR CONTRIBUTOR FOR FRACTURE NOT REPORTED TO THE REP). AN ACCOLADE II STEM, 40 +12 METAL HEAD, AND 40F 0° LINER WERE REVISED TO AN MDM/ADM LINER CONSTRUCT WITH COMPETITOR STEM AND HEAD. REP PROVIDED A POST-REVISION X-RAY AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8373644 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD GROIN/THIGH PAIN REQUIRING A REVISION OF THE FEMORAL STEM. WE REMOVED AN ACCOLADE 2 STEM AND REPLACED IT WITH A RESTORATION MODULAR.

  Patient problems: Injury; Pain

  MAUDE report 8372199 ↗
• InjuryFeb 21, 2019Loss of Osseointegration; Loss of Osseointegration

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT BILATERAL TOTAL HIP REPLACEMENT (B)(6) 2013. THE PATIENT HAD A LEFT PERIPROSTHETIC FRACTURE WITH A LOOSE FEMORAL COMPONENT. REVISED ON (B)(6) 2013. ALL COMPONENTS EXCHANGED EXCEPT CUP AND LINER.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8357504 ↗
• InjuryJun 11, 2018Degraded; Material Deformation; Degraded; Material Deformation

  FRETTING BETWEEN HEAD AND STEM CONE WITH METALLOSIS FOR TOTAL ENDOPROSTHESIS IMPLANTATION ON THE RIGHT HIP JOINT ON (B)(6) 2016. IT WAS NECESSARY TO CHANGE THE MODULAR HEAD IMPLANT AND A SOFT TISSUE DECAY ON THE RIGHT HIP JOINT. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS INITIALLY VERY SATISFIED AFTER THE OPERATION, BUT SINCE (B)(6) 2017 INCREASING RIGHT GROIN PAIN. THE FURTHER DIAGNOSTIC INVESTIGATION WITH NMR OF THE AFFECTED HIP AND THE LUMBAR SPINE FOR THE EXCLUSION OF L2 SYMPTOMS DID NOT YIELD ANY FINDINGS THAT COULD HAVE EXPLAINED THE PATIENT'S COMPLAINTS. THEREFORE ON (B)(6) 2018 PUNCTURE OF THE RIGHT HIP. IT IS PUNCTURED A PASTE-LIKE TOUGH GRAYISH MASS. THE MACROSCOPIC FINDING WOULD FIT INTO A METALLOSIS. AN INFECTION IS EXCLUDED.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 7587784 ↗
• InjuryApr 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER A FRACTURE SUSTAINED IN A FALL (FRACTURE SITE NOT IDENTIFIED). UPDATE (B)(6) 2018: FRACTURE WAS A PROXIMAL FEMORAL FRACTURE.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 7388994 ↗